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本文(BS EN 13726-3-2003 Test methods for primary wound dressings - Waterproofness《主要伤口敷料试验方法 防水性》.pdf)为本站会员(postpastor181)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

BS EN 13726-3-2003 Test methods for primary wound dressings - Waterproofness《主要伤口敷料试验方法 防水性》.pdf

1、BRITISH STANDARD BS EN 13726-3:2003 Non-active medical devices Test methods for primary wound dressings Part 3: Waterproofness The European Standard EN 13726-3:2003 has the status of a British Standard ICS 11.120.20 BS EN 13726-3:2003 This British Standard was published under the authority of the St

2、andards Policy and Strategy Committee on 13 May 2003 BSI 13 May 2003 ISBN 0 580 41799 9 National foreword This British Standard is the official English language version of EN 13726-3:2003. The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices

3、, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this docum

4、ent may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract.

5、Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for cha

6、nge, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 6, an inside back cover and a back cover. The BSI copyright dat

7、e displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN137263 April2003 ICS11.120.20 Englishversion NonactivemedicaldevicesTestmethodsforprimarywound dressingsPart3:Waterproo

8、fness DispositifsmdicauxnonactifsMthodesdessaipourles pansementsprimairesencontactaveclaplaiePartie3: Rsistancelapntrationdeleau NichtaktiveMedizinproduktePrverfahrenfrprimre Verbandstoffe(Wundauflagen)Teil3:Wasserdichtheit ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtoco

9、mplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanS

10、tandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic

11、,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Br

12、ussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN137263:2003EEN137263:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope 4 2 Termsanddefinitions. .4 3 Testmethodforwaterproofness 4 3.1 Testconditions . .4 3.2 Waterproofness4 3.2.1 S

13、ignificanceanduse .4 3.2.2 Equipment.5 3.2.3 Procedure .5 3.2.4 Calculationofresults 5 3.2.5 Testreport . .5EN137263:2003(E) 3 Foreword Thisdocument(EN137263:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC205,“Nonactivemedical devices“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegive

14、nthestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyOctober2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2003. EN13726consistsofthefollowingPartsunderthegeneraltitle Nonactivemedicaldevices Testmethodsfor primarywounddressings: P

15、art1:Aspectsofabsorbency Part2:Moisturevapourtransmissionrateofpermeablefilmdressings Part3:Waterproofness Part4:Conformability Part5:Bacterialbarrierproperties Part6:Odourcontrol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplemen

16、tthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Slovakia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EN137263:2003(E) 4 Introduction EN13726givestestmethodsanddoesnotcontainperforma

17、ncerequirements. EN137263describesatestmethodforwaterproofnessofprimarywounddressings. TestmethodsforotheraspectsofprimarywounddressingsaredescribedinotherpartsofEN13726. 1Scope ThisEuropeanStandarddescribesatestmethodfortheevaluationofwaterproofnessofprimarywounddressings whensuchclaimsaremade. 2 T

18、ermsanddefinitions ForthepurposesofthisEuropeanStandard,thefollowingtermsanddefinitionsapply: 2.1 primarywounddressing materialorcombinationofmaterials,inanyshape,formorsizethatisintendedtoremainindirectcontactwitha wound NOTE Primarywounddressingsareusedasmechanicalbarriers,fortheabsorptionortransm

19、issionofexudates,to managethemicroenvironmentofthewound,andcanenablethewoundtohealbyprimaryorsecondaryintent.Deviceswhich haveametabolic,pharmacologicalorimmunologicalinteractionastheirprimaryintentareexcluded 2.2 waterproof(ness) abilitytowithstandahydrostaticheadof500mmwaterfor300s 3 Testmethodfor

20、waterproofness 3.1Test conditions Conditionthesampleforatleast16hatof(6015)%RHandatemperatureof(212)Candcarryoutthetest inthesameenvironment. 3.2Waterproofness 3.2.1 Significanceanduse Thetestisdesignedtoassesswhetheraprimarywounddressingiswaterproof. NOTE1 Thistestmaynotbesuitableforsometypesofprim

21、arywounddressingse.g.somehydrocolloids. NOTE2 Thistestmaynotbeabletodetectthewaterproofnessofsomeslowlyhydratingprimarywounddressingswhere hydrationisnotachievedduringthedurationofthetest.EN137263:2003(E) 5 3.2.2Equipment 3.2.2.1 Apparatusformeasurementofwaterproofness(seeFigure1),consistingofacellw

22、hichallowsthe applicationofahydrostaticheadof500mmofwaterfor300stoacircularareaofthespecimenwiththesurface oppositetothewoundcontactsidetowardsthewater.Thespecimenisheldinahorizontalpositionbytworings, theloweroneformingpartofthecell.Ascrewdeviceallowsclampstobetightenedsoastopreventleakageof watero

23、rthemovementofthespecimenduringthetest.Thehydrostaticheadisgeneratedbymeansofavertical tubewithaminimuminternaldiameterof3mmconnectedtothebaseofthecell. NOTE Topreventleakagetheringsurfacesincontactwiththespecimenmayneedtobecoveredbyasuitablecoating materialsuchasrubber. 3.2.2.2 Distilled/deionisedw

24、ater. 3.2.2.3 Standardcellulosebasedfilterpaper. 3.2.3Procedure 3.2.3.1 Thespecimensshallbepreparedwithoutfolding. 3.2.3.2 Fillthecellcompletelywithpurifiedwaterat(212)C. 3.2.3.3 Placethespecimenonthelowerringbyslidingithorizontallyinsuchawayastoavoidtheinclusionof airbetweenthesurfaceofthewaterandt

25、helowersurfaceofthespecimen. 3.2.3.4 Covertheuppersurfaceofthespecimenwithadryfilterpaperlargerthanthetestarea,locatetheupper ring,andtightenthescrewdevice. 3.2.3.5 Pourwaterintothetubeuntiltherequiredlevelabovethesurfaceofthespecimenisreached. 3.2.3.6 Maintainthehydrostaticheadfor(30010)s. 3.2.3.7

26、Examinethefilterpaperforpenetrationofwaterthroughthespecimenandrecordtheresult. 3.2.3.8 Repeat3.2.3.2to3.2.3.7onafurthertwospecimens. 3.2.4 Calculationofresults Examinethefilterpaperforpenetrationofwaterthroughthespecimenandrecordtheresults.Ifwaterpenetration hasoccurredonanyofthethreespecimensthesa

27、mplehasfailedthetest. 3.2.5 Testreport Thereportshallincludeatleastthefollowinginformation: a) typeofdressing,includinglotnumber; b) anydeviationsfromthetestmethod; c) whetherthesamplehaspassedorfailedthetest; d) dateoftest; e) identityoftheperson(s)whocarriedoutthetest.EN137263:2003(E) 6 Dimensions

28、inmillimetres Key 1Pressure 2Gasket 3 Filterpaper 4Sample 5Gasket Figure1ApparatusformeasurementofwaterproofnessblankBS EN 13726-3:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It pres

29、ents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BS

30、I to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8

31、996 9000. Fax: +44 (0)20 8996 7400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Custom

32、er Services. Tel: +44 (0)20 8996 9001. Fax: +44 (0)20 8996 7001. Email: ordersbsi-. Standards are also available from the BSI website at http:/www.bsi-. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British S

33、tandards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information services are also available which give details

34、 on all its products and services. Contact the Information Centre. Tel: +44 (0)20 8996 7111. Fax: +44 (0)20 8996 7048. Email: infobsi-. Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For details of thes

35、e and other benefits contact Membership Administration. Tel: +44 (0)20 8996 7002. Fax: +44 (0)20 8996 7001. Email: membershipbsi-. Information regarding online access to British Standards via British Standards Online can be found at http:/www.bsi- Further information about BSI is available on the BS

36、I website at http:/www.bsi-. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publications of the international standardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a

37、 retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. Details and advice can be obtained from the Copyright & Licensing Manager. Tel: +44 (0)20 8996 7070. Fax: +44 (0)20 8996 7553. Email: copyrightbsi-.

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